Trial · NCT04504032
A Trial to Evaluate Safety and Efficacy of Rivaroxaban (COVID-19)
NCT04504032, Phase 2, Terminated, Gates Medical Research Institute; results first posted 2021-10-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Trial to Evaluate Safety and Efficacy of Rivaroxaban (COVID-19). Trials, record NCT04504032. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04504032
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Trial to Evaluate Safety and Efficacy of Rivaroxaban (COVID-19)
- NCT number
- NCT04504032
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 497 participants, actual
- Lead sponsor
- Gates Medical Research Institute
- Conditions
- COVID-19
- Interventions
- Rivaroxaban, Placebo
- First posted
- 2020-08-07
- Last updated
- 2021-10-22
- Other registries' IDs
- eudract:2020-005395-35
- Results first posted
- 2021-10-22
- Limitations and caveats
- Based on Data Monitoring Committee's recommendation on 3 February 2021, the study was stopped on 4 February 2021 due to futility.
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Grade 3 and Grade 4 Adverse Events (AEs) Through Day 35 | Up to Day 35 | An AE is any untoward medical occurrence that occurs in a participant. An AE can be any unfavorable and unintended sign (including abnormal laboratory findings), symptom, or disease temporally associated with treatment, whether considered related to the product. AEs may include the onset of a new illness or undesirable medical condition or the exacerbation of pre-existing medical conditions. AE severity was graded as Grade 3 (Severe) and Grade 4 (Potentially Life-threatening) per the specific toxicity grading by the Division of Acquired Immunodeficiency Syndrome (DAIDS) AE Grading Table. |
| Primary | Number of Participants With AEs Resulting in Study Intervention Discontinuation Through Day 35 | Up to Day 35 | An AE is any untoward medical occurrence that occurs in a participant. An AE can be any unfavorable and unintended sign (including abnormal laboratory findings), symptom, or disease temporally associated with treatment, whether considered related to the product. AEs may include the onset of new illness or undesirable medical condition or the exacerbation of pre-existing medical conditions. |
| Primary | Number of Participants With Serious Adverse Events Through Day 35 | Up to Day 35 | A serious AE is any untoward medical occurrence or effect, that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; is an important medical event that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require intervention to prevent one of the other outcomes. |
| Primary | Number of Participants Who Progressed to Moderate or Severe Disease or Higher Based on the Gates MRI Ordinal Scale Through Day 28 | Up to Day 28 | Participants who progressed to a moderate or severe disease category or higher (Bill \& Melinda Gates Medical Research Institute \[Gates MRI\] ordinal scale ≥3) are reported. Gates MRI scale scores are assessed on a 7-point scale: 1=Asymptomatic/symptoms similar to pre-COVID-19 status; 2=Mild; 3=Moderate or severe; 4=Critically ill; 5=Critically ill with invasive mechanical ventilation or extrapulmonary complication; 6=Critically ill with Extra-Corporeal Membrane Oxygenation (ECMO); 7=Death. |
| Secondary | Median Time to Disease Resolution Based on Symptoms Resolution Through Day 28 | Up to Day 28 | Time to disease resolution is defined as the time from the first dose to the date of symptoms resolution (new-onset Coronavirus Disease 2019 \[COVID-19\] symptoms resolved, and pre-existing symptoms returned to Baseline) through Day 28. Baseline refers to health status prior to contracting new-onset COVID-19 symptoms. The 95% confidence interval (CI) for median and quartiles of time to disease resolution were calculated using the Kaplan Meier estimates. |
| Secondary | Median Time to Disease Resolution Based on Viral Clearance and Symptoms Resolution Through Day 28 | Up to Day 28 | Time to disease resolution is defined as the time from the first dose to the date of both viral clearance (two consecutive negative diagnostic tests) and symptoms resolution (new-onset COVID-19 symptoms resolved, and pre-existing symptoms returned to Baseline) through Day 28. Baseline refers to health status prior to contracting new-onset COVID-19 symptoms. The 95% CI for median and quartiles of time to disease resolution were calculated using the Kaplan Meier estimates. |
| Secondary | Number of Participants Who Progressed to Moderate or Severe Disease or Higher Based on the Gates MRI Ordinal Scale at Day 8, 14, and 21 | Days 8, 14, and 21 | Participants who progressed to a moderate or severe disease category or higher (Gates MRI ordinal scale ≥3) are reported. Gates MRI ordinal scale scores are assessed on a 7-point scale: 1=Asymptomatic/symptoms similar to pre-COVID-19 status; 2=Mild; 3=Moderate or severe; 4=Critically ill; 5=Critically ill with invasive mechanical ventilation or extrapulmonary complication; 6=Critically ill with ECMO; 7=Death. |
| Secondary | Number of Participants Who Achieved Disease Resolution Based on Symptoms Resolution at Days 8, 14, 21, and 28 | Days 8, 14, 21, and 28 | Symptoms resolution is defined as new-onset COVID-19 symptoms resolved, and pre-existing symptoms returned to Baseline. Baseline refers to health status prior to contracting new-onset COVID-19 symptoms. |
| Secondary | Number of Participants Who Achieved Disease Resolution Based on Viral Clearance and Symptoms Resolution at Days 8, 14, 21, and 28 | Days 8, 14, 21, and 28 | Viral clearance is defined as two consecutive negative diagnostic tests. Symptoms resolution is defined as new-onset COVID-19 symptoms resolved, and pre-existing symptoms returned to Baseline. Baseline refers to health status prior to contracting new-onset COVID-19 symptoms. |
| Secondary | Number of Participants With the Indicated Gates Medical Research Institute (MRI) Scale Clinical Status at Days 8, 14, 21, and 28 | Days 8, 14, 21, and 28 | Participants who progressed to a moderate or severe disease category or higher (Gates MRI ordinal scale ≥3) are reported. Gates MRI ordinal scale scores are assessed on a 7-point scale: 1=Asymptomatic/symptoms similar to pre-COVID-19 status; 2=Mild; 3=Moderate or severe; 4=Critically ill; 5=Critically ill with invasive mechanical ventilation or extrapulmonary complication; 6=Critically ill with ECMO; 7=Death. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Grade 3 and Grade 4 Adverse Events (AEs) Through Day 35 | Up to Day 35 | Safety Population: all participants randomly assigned to study intervention, who received the study intervention. Participants were grouped according to the study intervention they actually received. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With AEs Resulting in Study Intervention Discontinuation Through Day 35 | Up to Day 35 | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Serious Adverse Events Through Day 35 | Up to Day 35 | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Who Progressed to Moderate or Severe Disease or Higher Based on the Gates MRI Ordinal Scale Through Day 28 | Up to Day 28 | Intent-to-Treat (ITT) Population: All participants assigned to study intervention, who received the study intervention. Participants were grouped according to the study intervention to which they were randomized. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Median Time to Disease Resolution Based on Symptoms Resolution Through Day 28 | Up to Day 28 | ITT Population. Only those participants with available data were analyzed. | Days | MEDIAN |
| SECONDARY | Median Time to Disease Resolution Based on Viral Clearance and Symptoms Resolution Through Day 28 | Up to Day 28 | ITT Population. Only those participants with available data were analyzed. | Days | MEDIAN |
| SECONDARY | Number of Participants Who Progressed to Moderate or Severe Disease or Higher Based on the Gates MRI Ordinal Scale at Day 8, 14, and 21 | Days 8, 14, and 21 | ITT Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Achieved Disease Resolution Based on Symptoms Resolution at Days 8, 14, 21, and 28 | Days 8, 14, 21, and 28 | ITT Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Achieved Disease Resolution Based on Viral Clearance and Symptoms Resolution at Days 8, 14, 21, and 28 | Days 8, 14, 21, and 28 | ITT Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With the Indicated Gates Medical Research Institute (MRI) Scale Clinical Status at Days 8, 14, 21, and 28 | Days 8, 14, 21, and 28 | ITT Population. Only those participants with available data were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group668
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Grade 3 and Grade 4 Adverse Events (AEs) Through Day 35 | Rivaroxaban | 6 | Participants | ||
| Number of Participants With Grade 3 and Grade 4 Adverse Events (AEs) Through Day 35 | Placebo | 13 | Participants | ||
| Number of Participants With AEs Resulting in Study Intervention Discontinuation Through Day 35 | Rivaroxaban | 4 | Participants | ||
| Number of Participants With AEs Resulting in Study Intervention Discontinuation Through Day 35 | Placebo | 5 | Participants | ||
| Number of Participants With Serious Adverse Events Through Day 35 | Rivaroxaban | 2 | Participants | ||
| Number of Participants With Serious Adverse Events Through Day 35 | Placebo | 7 | Participants | ||
| Number of Participants Who Progressed to Moderate or Severe Disease or Higher Based on the Gates MRI Ordinal Scale Through Day 28 | Rivaroxaban | 46 | Participants | ||
| Number of Participants Who Progressed to Moderate or Severe Disease or Higher Based on the Gates MRI Ordinal Scale Through Day 28 | Placebo | 44 | Participants | ||
| Median Time to Disease Resolution Based on Symptoms Resolution Through Day 28 | Rivaroxaban | 21.0 | 95% Confidence Interval 19.0 to 23.0 | Days | |
| Median Time to Disease Resolution Based on Symptoms Resolution Through Day 28 | Placebo | 23.0 | 95% Confidence Interval 20.0 to 27.0 | Days |
1 to 10 of 668Source ClinicalTrials.gov
See all 668 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Rivaroxaban | 246 | |
| Overall Study | STARTED | Placebo | 251 | |
| Overall Study | COMPLETED | Rivaroxaban | 210 | |
| Overall Study | COMPLETED | Placebo | 223 | |
| Overall Study | NOT COMPLETED | Rivaroxaban | 36 | |
| Overall Study | NOT COMPLETED | Placebo | 28 |
Source ClinicalTrials.gov
Adverse events20
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Urinary Tract Infection | Infections and infestations | Rivaroxaban | 4 | 219 | 4 |
| other | Urinary Tract Infection | Infections and infestations | Placebo | 0 | 230 | 0 |
| other | COVID -19/COVID-19 pneumonia/pneumonia | Infections and infestations | Rivaroxaban | 1 | 219 | 1 |
| other | COVID -19/COVID-19 pneumonia/pneumonia | Infections and infestations | Placebo | 5 | 230 | 5 |
| other | Headache | Nervous system disorders | Rivaroxaban | 3 | 219 | 3 |
| other | Headache | Nervous system disorders | Placebo | 4 | 230 | 4 |
| other | Hematuria | Renal and urinary disorders | Rivaroxaban | 3 | 219 | 3 |
| other | Hematuria | Renal and urinary disorders | Placebo | 0 | 230 | 0 |
| other | Dyspnea | Respiratory, thoracic and mediastinal disorders | Rivaroxaban | 1 | 219 | 1 |
| other | Dyspnea | Respiratory, thoracic and mediastinal disorders | Placebo | 3 | 230 | 3 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rivaroxaban | 0 | 219 |
| Total, all-cause mortality | Placebo | 0 | 230 |
| Total, other adverse events | Rivaroxaban | 12 | 219 |
| Total, other adverse events | Placebo | 11 | 230 |
| Total, serious adverse events | Rivaroxaban | 2 | 219 |
| Total, serious adverse events | Placebo | 7 | 230 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Rivaroxaban vs Placebo: Number of Participants Who Progressed to Moderate or Severe Disease or Higher Based on the Gates MRI Ordinal Scale Through Day 28 | Trial comparisons |
| Rivaroxaban vs Placebo: Number of Participants With AEs Resulting in Study Intervention Discontinuation Through Day 35 | Trial comparisons |
| Rivaroxaban vs Placebo: Number of Participants With Grade 3 and Grade 4 Adverse Events (AEs) Through Day 35 | Trial comparisons |
| Rivaroxaban vs Placebo: Number of Participants With Serious Adverse Events Through Day 35 | Trial comparisons |
| Rivaroxaban vs Placebo: deaths from any cause | Trial comparisons |
| Rivaroxaban vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04504032
GET https://conductscience.org/api/trials/v1/NCT04504032/results?page=2